Program Manager / Project Manager (Design Control / Medical Device)

Description

This is an onsite opportunity in Santa Clara, CA.

• Engineering or Science Background
• Medical device background
• Works with cross functional R &D Team
• Good Communicator
• Gain Trust of their team
• Understand Phase Gate

Description:

• This position manages programs of small to medium scope, or a significant subsection of a large program. As an R&D Project Manager, you will be expected to lead cross-functional teams to develop and execute strategies for new product development and successful commercialization.
• In this role you will manage matrixed resources to ensure programs meet their agreed upon milestones and deliverables, represent the program to the organization and report core team progress, program recommendations, risks, and resolutions of issues to senior leadership.

What you’ll work on:

• Lead cross-functional teams through project planning exercises to develop detailed schedules and integrated project plans.
• Utilize project scheduling software to plan and track tasks using tools such as MS Project and Smartsheet. Work with appropriate staff to understand tasks necessary to complete project.
• Communicate with all levels of the organization to represent the objectives, risks, and needs for the program.
• Lead activities across numerous functions to meet the objectives of a given program including scope and schedule.
• Establish and maintain the program and product Design History File in partnership with the Program Director and fellow core team members.
• Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
• Develops plans with core members to eliminate and/or mitigate risk. If risks cannot be mitigated within the core team, determines appropriate means to communicate and elevate issues to appropriate individuals within the organization.
• In partnership with the Director, identifies opportunities for improving overall performance of the program.
• Works closely with functional core team leaders and mentor when necessary.
• Assures project quality by using standard development methodologies and by working with quality engineering team to develop and execute project quality plans.
• Resolve project issues by working with team members, project customers, and others as appropriate.
• Establishes priorities of individual or project assignments. Selects methods and techniques to lead a project to completion.
• Maintain a safe and professional work environment.
• Comply with worldwide medical device regulations including U.S. FDA, company policies and Good Manufacturing Practices.

Required Qualifications:

• Bachelor’s Degree in Engineering or Science equivalent
• 5+ years of experience required for progressively responsible experience in engineering or related technical discipline.
• Demonstrated expertise in Project Management tools and processes.
• Has successfully led several high complexity projects from beginning to end. 

Preferred Qualifications:

• PMP (Project Management Professional) qualification preferred.
• Experience in Project Management tools such as MS Project or Smartsheet
• Requires strong leadership, influencing and negotiation skills.
• Experience with complex mechanical devices.
• Ideally the candidate has a general knowledge of regulations and standards related to medical devices (e.g. FDA, ISO, QSR design controls).